Ultraviolet related deoxyribonucleic acid damage in skin of patients with atopic dermatitis and atopic status in relation to the use of Myfortic®

ISRCTN	ISRCTN23778671
DOI	https://doi.org/10.1186/ISRCTN23778671
Secondary identifying numbers	14196

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 05/12/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr M S de Bruin-Weller
Scientific

University Medical Center Utrecht
Department of Dermatology
HPN G02 124
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2509111
Email	m.s.debruin-weller@umcutrecht.nl

Study information

Study design	Clinical Trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Effect of Myfortic® on UV-induced DNA-damage and atopic status
Study objectives	Our hypothesis is that in patients with atopic dermatitis which use topical tacrolimus 0.1% the repair of DeoxyriboNucleic Acid (DNA)-damage in the skin is delayed. The repair of DNA-damage in the skin of patients with atopic dermatitis which use a class II corticosteroid is not delayed.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Atopic dermatitis
Intervention	Ten patients in total with atopic dermatitis are to be included in the study. The inclusion takes place after the physician has indicated that treatment with oral immunosuppressive drugs is necessary. The informed consent intake will be performed by the researcher. At inclusion a screening will be done to evaluate the severity of the eczema and the atopic state (total and specific Immunoglobulin E [IgE], skin-prick test and atopy patch test) of the patient. Subsequently we will compare UV-irradiated, non-lesional skin prior to treatment (control) to UV-irradiated, non-lesional skin treated with Myfortic® during 12 weeks (intervention). The Minimal Erythema Dose (MED) will be determined prior to actual irradiation. Punch biopsies will be taken immediately after irradiation with two MED and after 24 hours. A reference biopsy will be taken from skin that is not irrradiated. The whole process will be repeated after 12 weeks of treatment. To evaluate the atopic status after 12 weeks of treatment, we will repeat the skin-prick test and atopy patch test. The final clinical evaluation of therapy will be performed after 16 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Myfortic®
Primary outcome measure	The difference between the percentage in repair of Cyclobutane Pyrimidine Dimers (CPD's) before and after treatment with Myfortic® is the primary study outcome.
Secondary outcome measures	1. The atopic state before and after treatment with Myfortic®. 2. The evaluation of the efficacy of initial high dosing with Myfortic® in order to induce rapid improvement of the disease.
Overall study start date	01/10/2006
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	10
Key inclusion criteria	1. Age from 18 years 2. Atopic dermatitis according to the criteria of Hanifin and Rajka 3. Insufficient response to topical therapy alone 4. The physician estimates that treatment with oral immunosuppressive agents is indicated
Key exclusion criteria	1. Patients with any known hypersensitivity to mycofenolic acid or other components of the formulation 2. Oral immunosuppressive treatment in the last six weeks 3. Concomitant Ultraviolet (UV) therapy or UV therapy in the last two months 4. Contact with UV on the lesional skin for the last two months 5. Patients with thrombocytopenia (less than 75,000/mm^3), with an absolute neutrophil count less than 1,500/mm^3 and/or leukocytopenia (less than 2,500/mm^3) and/or haemoglobin less than 6.0 g/dl prior to enrolment 6. Patients who have received an investigational drug within two weeks prior to screening 7. Patients with a history of malignancy within the last five years 8. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception 9. Patients with an immunologic disorder (like Rheumatoid Arthritis [RA], Systemic Lupus Erythematosus [SLE] or M. SjÖgren) or a pre-existent dermatologic disorder that worsens in combination with UV (like LE or photosensitive eczema) 10. Presence of clinically significant infection requiring continued therapy, severe diarrhoea or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study
Date of first enrolment	01/10/2006
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht

Utrecht
3508 GA
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Department of Dermatology and Allergology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

"ROR"	https://ror.org/0575yy874

Funders

Funder type

Industry

Novartis Pharma B.V.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan